1.Study Design and Protocol for a Randomized Controlled Trial of Enavogliflozin to Evaluate Cardiorenal Outcomes in Type 2 Diabetes (ENVELOP)
Nam Hoon KIM ; Soo LIM ; In-Kyung JEONG ; Eun-Jung RHEE ; Jun Sung MOON ; Ohk-Hyun RYU ; Hyuk-Sang KWON ; Jong Chul WON ; Sang Soo KIM ; Sang Yong KIM ; Bon Jeong KU ; Heung Yong JIN ; Sin Gon KIM ; Bong-Soo CHA ;
Diabetes & Metabolism Journal 2025;49(2):225-234
Background:
The novel sodium-glucose cotransporter-2 (SGLT2) inhibitor enavogliflozin effectively lowers glycosylated hemoglobin levels and body weights without the increased risk of serious adverse events; however, the long-term clinical benefits of enavogliflozin in terms of cardiovascular and renal outcomes have not been investigated.
Methods:
This study is an investigator-initiated, multicenter, randomized, pragmatic, open-label, active-controlled, non-inferiority trial. Eligible participants are adults (aged ≥19 years) with type 2 diabetes mellitus (T2DM) who have a history of, or are at risk of, cardiovascular disease. A total of 2,862 participants will be randomly assigned to receive either enavogliflozin or other SGLT2 inhibitors with proven cardiorenal benefits, such as dapagliflozin or empagliflozin. The primary endpoint is the time to the first occurrence of a composite of major adverse cardiovascular or renal events (Clinical Research Information Service registration number: KCT0009243).
Conclusion
This trial will determine whether enavogliflozin is non-inferior to dapagliflozin or empagliflozin in terms of cardiorenal outcomes in patients with T2DM and cardiovascular risk factors. This study will elucidate the role of enavogliflozin in preventing vascular complications in patients with T2DM.
2.Study Design and Protocol for a Randomized Controlled Trial of Enavogliflozin to Evaluate Cardiorenal Outcomes in Type 2 Diabetes (ENVELOP)
Nam Hoon KIM ; Soo LIM ; In-Kyung JEONG ; Eun-Jung RHEE ; Jun Sung MOON ; Ohk-Hyun RYU ; Hyuk-Sang KWON ; Jong Chul WON ; Sang Soo KIM ; Sang Yong KIM ; Bon Jeong KU ; Heung Yong JIN ; Sin Gon KIM ; Bong-Soo CHA ;
Diabetes & Metabolism Journal 2025;49(2):225-234
Background:
The novel sodium-glucose cotransporter-2 (SGLT2) inhibitor enavogliflozin effectively lowers glycosylated hemoglobin levels and body weights without the increased risk of serious adverse events; however, the long-term clinical benefits of enavogliflozin in terms of cardiovascular and renal outcomes have not been investigated.
Methods:
This study is an investigator-initiated, multicenter, randomized, pragmatic, open-label, active-controlled, non-inferiority trial. Eligible participants are adults (aged ≥19 years) with type 2 diabetes mellitus (T2DM) who have a history of, or are at risk of, cardiovascular disease. A total of 2,862 participants will be randomly assigned to receive either enavogliflozin or other SGLT2 inhibitors with proven cardiorenal benefits, such as dapagliflozin or empagliflozin. The primary endpoint is the time to the first occurrence of a composite of major adverse cardiovascular or renal events (Clinical Research Information Service registration number: KCT0009243).
Conclusion
This trial will determine whether enavogliflozin is non-inferior to dapagliflozin or empagliflozin in terms of cardiorenal outcomes in patients with T2DM and cardiovascular risk factors. This study will elucidate the role of enavogliflozin in preventing vascular complications in patients with T2DM.
3.Study Design and Protocol for a Randomized Controlled Trial of Enavogliflozin to Evaluate Cardiorenal Outcomes in Type 2 Diabetes (ENVELOP)
Nam Hoon KIM ; Soo LIM ; In-Kyung JEONG ; Eun-Jung RHEE ; Jun Sung MOON ; Ohk-Hyun RYU ; Hyuk-Sang KWON ; Jong Chul WON ; Sang Soo KIM ; Sang Yong KIM ; Bon Jeong KU ; Heung Yong JIN ; Sin Gon KIM ; Bong-Soo CHA ;
Diabetes & Metabolism Journal 2025;49(2):225-234
Background:
The novel sodium-glucose cotransporter-2 (SGLT2) inhibitor enavogliflozin effectively lowers glycosylated hemoglobin levels and body weights without the increased risk of serious adverse events; however, the long-term clinical benefits of enavogliflozin in terms of cardiovascular and renal outcomes have not been investigated.
Methods:
This study is an investigator-initiated, multicenter, randomized, pragmatic, open-label, active-controlled, non-inferiority trial. Eligible participants are adults (aged ≥19 years) with type 2 diabetes mellitus (T2DM) who have a history of, or are at risk of, cardiovascular disease. A total of 2,862 participants will be randomly assigned to receive either enavogliflozin or other SGLT2 inhibitors with proven cardiorenal benefits, such as dapagliflozin or empagliflozin. The primary endpoint is the time to the first occurrence of a composite of major adverse cardiovascular or renal events (Clinical Research Information Service registration number: KCT0009243).
Conclusion
This trial will determine whether enavogliflozin is non-inferior to dapagliflozin or empagliflozin in terms of cardiorenal outcomes in patients with T2DM and cardiovascular risk factors. This study will elucidate the role of enavogliflozin in preventing vascular complications in patients with T2DM.
4.Study Design and Protocol for a Randomized Controlled Trial of Enavogliflozin to Evaluate Cardiorenal Outcomes in Type 2 Diabetes (ENVELOP)
Nam Hoon KIM ; Soo LIM ; In-Kyung JEONG ; Eun-Jung RHEE ; Jun Sung MOON ; Ohk-Hyun RYU ; Hyuk-Sang KWON ; Jong Chul WON ; Sang Soo KIM ; Sang Yong KIM ; Bon Jeong KU ; Heung Yong JIN ; Sin Gon KIM ; Bong-Soo CHA ;
Diabetes & Metabolism Journal 2025;49(2):225-234
Background:
The novel sodium-glucose cotransporter-2 (SGLT2) inhibitor enavogliflozin effectively lowers glycosylated hemoglobin levels and body weights without the increased risk of serious adverse events; however, the long-term clinical benefits of enavogliflozin in terms of cardiovascular and renal outcomes have not been investigated.
Methods:
This study is an investigator-initiated, multicenter, randomized, pragmatic, open-label, active-controlled, non-inferiority trial. Eligible participants are adults (aged ≥19 years) with type 2 diabetes mellitus (T2DM) who have a history of, or are at risk of, cardiovascular disease. A total of 2,862 participants will be randomly assigned to receive either enavogliflozin or other SGLT2 inhibitors with proven cardiorenal benefits, such as dapagliflozin or empagliflozin. The primary endpoint is the time to the first occurrence of a composite of major adverse cardiovascular or renal events (Clinical Research Information Service registration number: KCT0009243).
Conclusion
This trial will determine whether enavogliflozin is non-inferior to dapagliflozin or empagliflozin in terms of cardiorenal outcomes in patients with T2DM and cardiovascular risk factors. This study will elucidate the role of enavogliflozin in preventing vascular complications in patients with T2DM.
5.Novel Deep Learning-Based Vocal Biomarkers for Stress Detection in Koreans
Junghyun NAMKUNG ; Seok Min KIM ; Won Ik CHO ; So Young YOO ; Beomjun MIN ; Sang Yool LEE ; Ji-Hye LEE ; Heyeon PARK ; Soyoung BAIK ; Je-Yeon YUN ; Nam Soo KIM ; Jeong-Hyun KIM
Psychiatry Investigation 2024;21(11):1228-1237
Objective:
The rapid societal changes have underscored the importance of effective stress detection and management. Chronic mental stress significantly contributes to both physical and psychological illnesses. However, many individuals often remain unaware of their stress levels until they face physical health issues, highlighting the necessity for regular stress monitoring. This study aimed to investigate the effectiveness of vocal biomarkers in detecting stress levels among healthy Korean employees and to contribute to digital healthcare solutions.
Methods:
We conducted a multi-center clinical study by collecting voice recordings from 115 healthy Korean employees under both relaxed and stress-induced conditions. Stress was induced using the socially evaluated cold pressor test. The Emphasized Channel Attention, Propagation and Aggregation in Time delay neural network (ECAPA-TDNN) deep learning architecture, renowned for its advanced capabilities in analyzing person-specific voice features, was employed to develop stress prediction scores.
Results:
The proposed model achieved a 70% accuracy rate in detecting stress. This performance underscores the potential of vocal biomarkers as a convenient and effective tool for individuals to self-monitor and manage their stress levels within digital healthcare frameworks.
Conclusion
The findings emphasize the promise of voice-based mental stress assessments within the Korean population and the importance of continued research on vocal biomarkers across diverse linguistic demographics.
6.Guideline for Minimizing Radiation Exposure of Interventionalists during Fluoroscopy-guided Interventional Procedures
Il Sang SHIN ; Yun Nah LEE ; Jun Kyu LEE ; Joo Seong KIM ; Sung Bum KIM ; Jiyoung KEUM ; Chang Hoon OH ; Kang Won LEE ; Joowon CHUNG ; Lyo Min KWON ; Nam Hee KIM ; Sang Soo LEE ; Byoung Kwan SON ; Miyoung CHOI
The Korean Journal of Gastroenterology 2024;84(6):251-264
As fluoroscopy-guided interventional procedures gain popularity, the associated health threats from radiation exposure to interventionalists during these procedures are increasing. Therefore, an understanding of the potential risks of radiation and careful consideration on minimizing exposure to radiation during the procedures are of paramount importance. The Korean Pancreatobiliary Association has developed a clinical practice guideline to minimize radiation exposure during fluoroscopy-guided interventional procedures. This guideline provides recommendations to deal with the risk of radiation exposure to interventionalists who perform fluoroscopy-guided procedures, and emphasizes the importance of proper and practical approaches to avoid unnecessary radiation exposure.
7.Novel Deep Learning-Based Vocal Biomarkers for Stress Detection in Koreans
Junghyun NAMKUNG ; Seok Min KIM ; Won Ik CHO ; So Young YOO ; Beomjun MIN ; Sang Yool LEE ; Ji-Hye LEE ; Heyeon PARK ; Soyoung BAIK ; Je-Yeon YUN ; Nam Soo KIM ; Jeong-Hyun KIM
Psychiatry Investigation 2024;21(11):1228-1237
Objective:
The rapid societal changes have underscored the importance of effective stress detection and management. Chronic mental stress significantly contributes to both physical and psychological illnesses. However, many individuals often remain unaware of their stress levels until they face physical health issues, highlighting the necessity for regular stress monitoring. This study aimed to investigate the effectiveness of vocal biomarkers in detecting stress levels among healthy Korean employees and to contribute to digital healthcare solutions.
Methods:
We conducted a multi-center clinical study by collecting voice recordings from 115 healthy Korean employees under both relaxed and stress-induced conditions. Stress was induced using the socially evaluated cold pressor test. The Emphasized Channel Attention, Propagation and Aggregation in Time delay neural network (ECAPA-TDNN) deep learning architecture, renowned for its advanced capabilities in analyzing person-specific voice features, was employed to develop stress prediction scores.
Results:
The proposed model achieved a 70% accuracy rate in detecting stress. This performance underscores the potential of vocal biomarkers as a convenient and effective tool for individuals to self-monitor and manage their stress levels within digital healthcare frameworks.
Conclusion
The findings emphasize the promise of voice-based mental stress assessments within the Korean population and the importance of continued research on vocal biomarkers across diverse linguistic demographics.
8.Guideline for Minimizing Radiation Exposure of Interventionalists during Fluoroscopy-guided Interventional Procedures
Il Sang SHIN ; Yun Nah LEE ; Jun Kyu LEE ; Joo Seong KIM ; Sung Bum KIM ; Jiyoung KEUM ; Chang Hoon OH ; Kang Won LEE ; Joowon CHUNG ; Lyo Min KWON ; Nam Hee KIM ; Sang Soo LEE ; Byoung Kwan SON ; Miyoung CHOI
The Korean Journal of Gastroenterology 2024;84(6):251-264
As fluoroscopy-guided interventional procedures gain popularity, the associated health threats from radiation exposure to interventionalists during these procedures are increasing. Therefore, an understanding of the potential risks of radiation and careful consideration on minimizing exposure to radiation during the procedures are of paramount importance. The Korean Pancreatobiliary Association has developed a clinical practice guideline to minimize radiation exposure during fluoroscopy-guided interventional procedures. This guideline provides recommendations to deal with the risk of radiation exposure to interventionalists who perform fluoroscopy-guided procedures, and emphasizes the importance of proper and practical approaches to avoid unnecessary radiation exposure.
9.Novel Deep Learning-Based Vocal Biomarkers for Stress Detection in Koreans
Junghyun NAMKUNG ; Seok Min KIM ; Won Ik CHO ; So Young YOO ; Beomjun MIN ; Sang Yool LEE ; Ji-Hye LEE ; Heyeon PARK ; Soyoung BAIK ; Je-Yeon YUN ; Nam Soo KIM ; Jeong-Hyun KIM
Psychiatry Investigation 2024;21(11):1228-1237
Objective:
The rapid societal changes have underscored the importance of effective stress detection and management. Chronic mental stress significantly contributes to both physical and psychological illnesses. However, many individuals often remain unaware of their stress levels until they face physical health issues, highlighting the necessity for regular stress monitoring. This study aimed to investigate the effectiveness of vocal biomarkers in detecting stress levels among healthy Korean employees and to contribute to digital healthcare solutions.
Methods:
We conducted a multi-center clinical study by collecting voice recordings from 115 healthy Korean employees under both relaxed and stress-induced conditions. Stress was induced using the socially evaluated cold pressor test. The Emphasized Channel Attention, Propagation and Aggregation in Time delay neural network (ECAPA-TDNN) deep learning architecture, renowned for its advanced capabilities in analyzing person-specific voice features, was employed to develop stress prediction scores.
Results:
The proposed model achieved a 70% accuracy rate in detecting stress. This performance underscores the potential of vocal biomarkers as a convenient and effective tool for individuals to self-monitor and manage their stress levels within digital healthcare frameworks.
Conclusion
The findings emphasize the promise of voice-based mental stress assessments within the Korean population and the importance of continued research on vocal biomarkers across diverse linguistic demographics.
10.Guideline for Minimizing Radiation Exposure of Interventionalists during Fluoroscopy-guided Interventional Procedures
Il Sang SHIN ; Yun Nah LEE ; Jun Kyu LEE ; Joo Seong KIM ; Sung Bum KIM ; Jiyoung KEUM ; Chang Hoon OH ; Kang Won LEE ; Joowon CHUNG ; Lyo Min KWON ; Nam Hee KIM ; Sang Soo LEE ; Byoung Kwan SON ; Miyoung CHOI
The Korean Journal of Gastroenterology 2024;84(6):251-264
As fluoroscopy-guided interventional procedures gain popularity, the associated health threats from radiation exposure to interventionalists during these procedures are increasing. Therefore, an understanding of the potential risks of radiation and careful consideration on minimizing exposure to radiation during the procedures are of paramount importance. The Korean Pancreatobiliary Association has developed a clinical practice guideline to minimize radiation exposure during fluoroscopy-guided interventional procedures. This guideline provides recommendations to deal with the risk of radiation exposure to interventionalists who perform fluoroscopy-guided procedures, and emphasizes the importance of proper and practical approaches to avoid unnecessary radiation exposure.

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